Ten subjects will be enrolled, 8 will receive BCI-838 and 2 will receive matching placebo.

Drug: BCI-838

BCI-838 100 mg or matching placebo administered once daily for 7 days

Experimental: BCI-838 Dosing Arm 2

Ten subjects will be enrolled, 8 will receive BCI-838 and 2 will receive matching placebo.

Drug: BCI-838

BCI-838 or matching placebo administered once daily for 7 days; the dose of BCI-838 will be determined based on the safety and PK data from the preceding dosing arm.

Experimental: BCI-838 Dosing Arm 3

Ten subjects will be enrolled, 8 will receive BCI-838 and 2 will receive matching placebo.

Drug: BCI-838

BCI-838 or matching placebo administered once daily for 7 days; the dose of BCI-838 will be determined based on the safety and PK data from the preceding dosing arm.

Detailed Description:

This study will evaluate the safety and tolerability following oral administration of multiple doses of BCI-838 in healthy male and female subjects. The pharmacokinetic profile of multiple oral doses of BCI-838 in healthy male and female subjects will also be assessed. In addition, the pharmacodynamic effects of BCI-838 on the central nervous system using quantitative electroencephalogram analysis will be studied.

Eligibility

Ages Eligible for Study:

18 Years to 55 Years (Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Adult male and female healthy volunteers, 18-55 years of age

Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive

Female subjects must have a negative pregnancy test at screening and admission. Females of childbearing potential (not at least 2 years postmenopausal or surgically sterile) must be using a reliable, medically acceptable form of contraception for at least 30 days prior to the screening visit and must agree to continue such use throughout the duration of the study and for 3 months after the final dose of study drug.

Good general health as determined by medical history and physical examination with no clinically significant medical findings and no clinically relevant medical or surgical history and no acute or ongoing conditions within the past 30 days

Able to participate and willing to give written informed consent and to comply with the study restrictions

Participation in a drug study within 60 days prior to drug administration.

Participation in more than 3 other drug studies in the 10 months preceding the start of this study

Donation or blood loss of more than 50 mL of blood within 60 days prior to the first drug administration. Donation of more than 1.5 liters of blood in the 10 months preceding the start of this study

Illness within 5 days prior to drug administration

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548703